MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD X-FORCE BALLOON DILATION CATHETER; URETEROSCOPIC BALLOON DILATION CATHETER

Model Number	998404
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the catheter leaked the water because the inflation device was broken before the use.
Additional Manufacturer Narrative
The reported event was confirmed as use-related.An eagle inflation device was returned open with its original packaging.An evaluation was completed by atrion medical on 30sep2020.The gauge needle was found to be out of the zero position when received.There were no other anomalies noted in the initial visual inspection.Testing was attempted.The device was connected to a pressure indicator, and as the plunger was pulled to fill the device with distilled water for aspiration, the device would not draw water and could hear air pulling in.The tip of the device was inserted into a flask of water and then pulled water into the device.Next, the device was re-connected to the pressure indicator, the latch was engaged, and the plunger was rotated clockwise to pressurize the device.As the plunger was rotated, the device started leaking from the o-ring/clamp area and would not build pressure.The clamps were removed from the device, and it was noted that the o-ring was dislocated and blown out of its assembled position.The o-ring was removed and replaced with a new one, and then the sample was reconnected to the pressure indicator to perform functional testing.The device was aspirated and then brought to pressure again.The device passed the pressure leak, pressure decay, and vacuum capability tests with no leaking observed.Due to the gauge being off zero as received in, the device failed the gauge accuracy portion of the functional testing.The device history record review was not required as the reported event was confirmed as use-related.The instructions for use were found adequate and state the following: "do not exceed 30 atm".H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that the catheter leaked the water because the inflation device was broken before the use.

• Brand Name: BARD X-FORCE BALLOON DILATION CATHETER
• Common Device Name: URETEROSCOPIC BALLOON DILATION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10586886
• Report Number: 1018233-2020-06207
• Device Sequence Number: 19531379
• Product Code: EZN
• UDI-Device Identifier: 10801741052641
• UDI-Public: (01)10801741052641
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 998404
• Device Catalogue Number: 998404
• Device Lot Number: BMCRAT02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1